Back to results

Exercise Prescription in Cardiac Rehabilitation

Primary Purpose

Percutaneous Coronary Intervention, Myocardial Infarction, Coronary Artery Bypass Graft

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Graded Exercise Stress test (GXT) with Target Heart Rate Range

Heart rate monitors

About this trial

This is an interventional treatment trial for Percutaneous Coronary Intervention focused on measuring Graded exercise testing, Cardiac rehab, Exercise Prescription, Target heart rate range, RPE

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who are referred with an eligible diagnosis to CR.
Patients with myocardial infarction, percutaneous coronary intervention, or bypass surgery

Exclusion Criteria:

Permanent Atrial fibrillation, as this would interfere with using a target heart rate range during cardiac rehabilitation.
Patients with pacemakers, as the polar heart rate monitor interferes with pacing lines on the telemetry system.
Stable angina, as chest pain could become a limiting factor as exercise training progresses, rather than using target heart rates.
Patients with high risk unrevascularized coronary artery disease including left main coronary disease >60% or proximal left anterior descending artery (LAD) >80%, per the discretion of the medical director.
Patients with heart transplant or left-ventricular assist device, as heart rates can be inaccurate and difficult to measure.
Patients who plan to attend fewer than 12 sessions of CR, for reasons that might include need to return to work, high copays, transportation, lack of insurance, or lack of interest in the program.
Patients who join the Baystate CR program after having completed more than 3 sessions of CR at a different CR program.
Major orthopedic limitations to exercise, such as history of amputation or exercise-limiting joint pain, or inability to walk on a treadmill, because all patients will have to complete a stress test on a treadmill and objective data collected during CR will be recorded during treadmill exercise.
Patients who plan to undergo a clinically indicated stress test in the next 3 months as this would potentially interfere with the exercise prescription in the control group.
Any elective hospitalization or revascularization procedure (such as PCI or CABG) that are planned to occur in the next 3 months. These could interrupt exercise training or change target heart rate ranges.
Any other condition in which exercise training or exercise testing would be contraindicated such as severe uncontrolled hypertension, diabetes, arrhythmia, or severe valvular disease, as determined by the Medical Director of Cardiac Rehabilitation.
Any other condition that would prohibit adherence to study protocols, such as active drug use, or untreated mental health conditions that would interfere with following instructions.
Patients judged to be at very high or high-risk of early drop-out, per current program risk stratification

Sites / Locations

Baystate Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Control Group Procedures (RPE based exercise)

Exercise Test and Heart Rate Range

Exercise Test, Heart Rate Range, and Heart Rate Monitor

Arm Description

Patients in the control group will follow standard exercise prescription protocols in CR. Exercise intensity will be guided by the patient's reported rating of perceived exertion (RPE). The modified Borg scale will be used by the patients to determine their RPE. Therefore, a scale of 1-10 will be used. The general goal will be to exercise between intensity level 3 or 4 (i.e. moderate intensity), per current program standards. Based on exercise levels achieved on the first day, patients will be given exercise recommendations for their 2nd session of CR and so forth. As the patients progress in CR, patients will increase their time, intensity, and mode of exercise as appropriate. Exercise progression will be guided by RPE and clinical assessment.

Patients randomly assigned to this group will complete a graded exercise test (GXT) per standard protocols. The researchers will obtain the patients peak heart rate from this stress test. Obtaining an accurate peak heart rate will allow for the calculation of a target heart rate range (THRR) using the Karvonen formula. Based upon the Karvonen formula, the THRR will be between 60-80% of the patient's heart rate reserve. The Karvonen formula can be calculated as follows ((peak heart rate - resting heart rate) X % intensity (0.6 or 0.8) + resting heart rate)). An example would be: (155 -75) X (.6) + 75) = 123; ((155 - 75) X (.8) + 75 = 139) THRR: 123 - 139. Patients will then adjust their exercise intensity to match this target heart rate range for the duration of their time in cardiac rehabilitation. Cardiac rehabilitation staff will provide feedback about heart rate when they are able.

Patients randomly assigned to this group will also undergo a stress test (GXT) and exercise within a target heart rate range (THRR) during cardiac rehabilitation comparable to second arm of the trial. Additionally, they will receive a personal heart rate monitor (HRM). This monitor will consist of a polar heart rate chest strap and polar watch. Patients will be asked to wear this during cardiac rehabilitation and adjust their own exercise intensity. This will provide continuous feedback to the patient about their heart rate. Cardiac rehabilitation staff will also provide feedback when available. The investigators are using the heart rate monitors because cardiac rehab staff are not always able to adjust exercise intensity for all patients, and telemetry is not always used.

Outcomes

Primary Outcome Measures

Recruit 60 patients

The number of patients that signed informed consent to participate in the study

Retain patients for at least 12 exercise sessions of cardiac rehab

The percentage of patients that exercised for at least 12 sessions of cardiac rehab

Secondary Outcome Measures

Peak exercise capacity at the completion of cardiac rehabilitation

Peak VO2 as measured on a maximal cardiopulmonary stress test

Change in functional exercise capacity from baseline to end of cardiac rehab

The change in functional exercise capacity as measured in METS as calculated using the online formula, http://www.fedel.com/mets/, obtained from calibrated treadmill speed and incline during usual exercise training workloads.

Adherence to Cardiac Rehabilitation (CR)

Total number of CR sessions completed

Change in Patient Exercise Confidence

Patients confidence, fear, and anxiety will be measured using surveys at baseline, after 6 sessions of cardiac rehab, and at the end of cardiac rehab. The confidence ruler is a 0 to 10 scale. A higher score on the confidence survey, indicates a greater level of confidence. A minimum score of 0 and a max score of 10 will be used per question, therefore, patients can receive a minimum score of 0 (low confidence) and a maximum score of 100 (high confidence). Fear and Anxiety will be measured using an anxiety questionnaire. Each question has a scale from 1 to 5 indicting very little fear to very fearful. A lower score on the anxiety scale indicates less anxiety or fear. Patients can receive a score from 6 (very little fear) to 30 (very fearful).

The number of patients with at least one or more adverse events in CR

The percentage of patients that have an adverse clinical event that precludes or stops exercise during cardiac rehabilitation. The adverse event is determined by the opinion of the treating clinician, the patient was unable to start or continue exercising based on one or more of the following subcategories; high or low blood pressure, dyspnea, tachycardia, or chest pain as defined by the treating clinician who stopped or precluded exercise.

Full Information

NCT ID

NCT03925493

First Posted

April 5, 2019

Last Updated

January 11, 2021

Sponsor

Baystate Medical Center

Collaborators

Springfield College

1. Study Identification

Unique Protocol Identification Number

NCT03925493

Brief Title

Exercise Prescription in Cardiac Rehabilitation

Official Title

Exercise Prescription in Cardiac Rehabilitation: A Pilot Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

June 17, 2019 (Actual)

Primary Completion Date

March 16, 2020 (Actual)

Study Completion Date

September 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baystate Medical Center

Collaborators

Springfield College

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Cardiac Rehabilitation (CR) is an effective exercise-based lifestyle therapy for patients with cardiac disease. There are two common methods of exercise prescription, an effort based exercise prescription and target heart rate based exercise prescription. The purpose of this research study is to identify the best way to exercise in cardiac rehabilitation. There are three main goals of this study. First, the investigators want to know if an exercise test should be done near the beginning of cardiac rehabilitation. Second, the investigators want to understand what type of exercises should be recommend to patients. Third, the investigators want to understand if a personal heart rate monitor will improve adherence to a target heart rate for exercise. As part of this study, some patients will undergo an exercise stress test on a treadmill to determine a target heart rate. These patients will be given a heart rate goal to use when they exercise. Some patients will be given a personal heart rate monitor to improve adherence.

Detailed Description

Cardiac Rehabilitation (CR) is an effective exercise-based lifestyle therapy for patients with cardiac disease that reduces cardiovascular morbidity and mortality, increases quality of life, and is cost-effective. Recent retrospective studies show that higher exercise gains during CR are associated with reduced long-term morbidity and mortality among patients with both coronary artery disease and systolic heart failure. However, it is unclear which methods maximize exercise gains in CR. Recent retrospective studies have suggested that performing stress testing early in CR may allow for better tailoring of an exercise prescription and thus increase exercise gains. In this study, the investigators propose to do a randomized controlled trial of 60 patients at Baystate Medical Center CR, in which two thirds of the patients will undergo exercise testing prior to starting CR. The exercise test will determine the initial target heart rate range (THRR) and will also influence subsequent exercise progression. Additionally, half of the patients undergoing a stress test will receive a personal heart rate monitor to help improve adherence to the exercise prescription and THRR. The primary outcome is to determine feasibility, protocol fidelity, and effect sizes in preparation for a fully powered subsequent trial that will measure the impact of stress testing and a target heart rage range exercise prescription on exercise gain during CR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Percutaneous Coronary Intervention, Myocardial Infarction, Coronary Artery Bypass Graft

Keywords

Graded exercise testing, Cardiac rehab, Exercise Prescription, Target heart rate range, RPE

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group Procedures (RPE based exercise)

Arm Type

No Intervention

Arm Description

Arm Title

Exercise Test and Heart Rate Range

Arm Type

Experimental

Arm Description

Arm Title

Exercise Test, Heart Rate Range, and Heart Rate Monitor

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Graded Exercise Stress test (GXT) with Target Heart Rate Range

Intervention Description

Patients assigned to one of two intervention groups will complete a GXT prior to the 4th CR session. The GXT will be completed in Baystate Medical Center's stress lab using standard protocols. This test will be used to set the target heart rate range, which will guide exercise intensity for the remainder of exercise training in cardiac rehabilitation.

Intervention Type

Behavioral

Intervention Name(s)

Heart rate monitors

Intervention Description

Heart rate monitors (HRM) will be given to half of the patients randomly assigned to exercise stress testing group. Patients will receive a polar heart rate chest strap and polar watch. Patients will be asked to wear both, the chest strap and the watch during cardiac rehabilitation. Ultimately, we hope that the use of HRM is not necessary, but it may be needed to assure that patients in the THHR are able to consistently know their HR and adjust their exercise prescription. This will also increase the likelihood that there is a difference in heart rates between the THRR group from the RPE group.

Primary Outcome Measure Information:

Title

Recruit 60 patients

Description

The number of patients that signed informed consent to participate in the study

Time Frame

One year

Title

Retain patients for at least 12 exercise sessions of cardiac rehab

Description

The percentage of patients that exercised for at least 12 sessions of cardiac rehab

Time Frame

within 3 months of recruitment

Secondary Outcome Measure Information:

Title

Peak exercise capacity at the completion of cardiac rehabilitation

Description

Peak VO2 as measured on a maximal cardiopulmonary stress test

Time Frame

Within 6 months of study enrollment

Title

Change in functional exercise capacity from baseline to end of cardiac rehab

Description

Time Frame

Within 6 months of study enrollment

Title

Adherence to Cardiac Rehabilitation (CR)

Description

Total number of CR sessions completed

Time Frame

Within 6 months of enrollment

Title

Change in Patient Exercise Confidence

Description

Time Frame

Within 6 months of enrollment

Title

The number of patients with at least one or more adverse events in CR

Description

Time Frame

Within 6 months of enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who are referred with an eligible diagnosis to CR. Patients with myocardial infarction, percutaneous coronary intervention, or bypass surgery Exclusion Criteria: Permanent Atrial fibrillation, as this would interfere with using a target heart rate range during cardiac rehabilitation. Patients with pacemakers, as the polar heart rate monitor interferes with pacing lines on the telemetry system. Stable angina, as chest pain could become a limiting factor as exercise training progresses, rather than using target heart rates. Patients with high risk unrevascularized coronary artery disease including left main coronary disease >60% or proximal left anterior descending artery (LAD) >80%, per the discretion of the medical director. Patients with heart transplant or left-ventricular assist device, as heart rates can be inaccurate and difficult to measure. Patients who plan to attend fewer than 12 sessions of CR, for reasons that might include need to return to work, high copays, transportation, lack of insurance, or lack of interest in the program. Patients who join the Baystate CR program after having completed more than 3 sessions of CR at a different CR program. Major orthopedic limitations to exercise, such as history of amputation or exercise-limiting joint pain, or inability to walk on a treadmill, because all patients will have to complete a stress test on a treadmill and objective data collected during CR will be recorded during treadmill exercise. Patients who plan to undergo a clinically indicated stress test in the next 3 months as this would potentially interfere with the exercise prescription in the control group. Any elective hospitalization or revascularization procedure (such as PCI or CABG) that are planned to occur in the next 3 months. These could interrupt exercise training or change target heart rate ranges. Any other condition in which exercise training or exercise testing would be contraindicated such as severe uncontrolled hypertension, diabetes, arrhythmia, or severe valvular disease, as determined by the Medical Director of Cardiac Rehabilitation. Any other condition that would prohibit adherence to study protocols, such as active drug use, or untreated mental health conditions that would interfere with following instructions. Patients judged to be at very high or high-risk of early drop-out, per current program risk stratification

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter K Lindenauer, MD

Organizational Affiliation

Baystate Medical Center

Official's Role

Study Director

Facility Information:

Facility Name

Baystate Medical Center

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01199

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 12 months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement

Citations:

PubMed Identifier

21735386

Citation

Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.

Results Reference

background

PubMed Identifier

26897640

Citation

Brawner CA, Abdul-Nour K, Lewis B, Schairer JR, Modi SS, Kerrigan DJ, Ehrman JK, Keteyian SJ. Relationship Between Exercise Workload During Cardiac Rehabilitation and Outcomes in Patients With Coronary Heart Disease. Am J Cardiol. 2016 Apr 15;117(8):1236-41. doi: 10.1016/j.amjcard.2016.01.018. Epub 2016 Jan 28.

Results Reference

background

PubMed Identifier

23062530

Citation

Keteyian SJ, Leifer ES, Houston-Miller N, Kraus WE, Brawner CA, O'Connor CM, Whellan DJ, Cooper LS, Fleg JL, Kitzman DW, Cohen-Solal A, Blumenthal JA, Rendall DS, Pina IL; HF-ACTION Investigators. Relation between volume of exercise and clinical outcomes in patients with heart failure. J Am Coll Cardiol. 2012 Nov 6;60(19):1899-905. doi: 10.1016/j.jacc.2012.08.958. Epub 2012 Oct 10.

Results Reference

background

PubMed Identifier

28185659

Citation

Brawner CA, Al-Mallah MH, Ehrman JK, Qureshi WT, Blaha MJ, Keteyian SJ. Change in Maximal Exercise Capacity Is Associated With Survival in Men and Women. Mayo Clin Proc. 2017 Mar;92(3):383-390. doi: 10.1016/j.mayocp.2016.12.016. Epub 2017 Feb 6.

Results Reference

background

PubMed Identifier

27755258

Citation

Keteyian SJ, Kerrigan DJ, Ehrman JK, Brawner CA. Exercise Training Workloads Upon Exit From Cardiac Rehabilitation in Men and Women: THE HENRY FORD HOSPITAL EXPERIENCE. J Cardiopulm Rehabil Prev. 2017 Jul;37(4):257-261. doi: 10.1097/HCR.0000000000000210.

Results Reference

background

PubMed Identifier

11565523

Citation

Ades PA. Cardiac rehabilitation and secondary prevention of coronary heart disease. N Engl J Med. 2001 Sep 20;345(12):892-902. doi: 10.1056/NEJMra001529. No abstract available.

Results Reference

background

PubMed Identifier

17893274

Citation

Suaya JA, Shepard DS, Normand SL, Ades PA, Prottas J, Stason WB. Use of cardiac rehabilitation by Medicare beneficiaries after myocardial infarction or coronary bypass surgery. Circulation. 2007 Oct 9;116(15):1653-62. doi: 10.1161/CIRCULATIONAHA.107.701466. Epub 2007 Sep 24.

Results Reference

background

PubMed Identifier

25098437

Citation

Pack QR, Squires RW, Lopez-Jimenez F, Lichtman SW, Rodriguez-Escudero JP, Zysek VN, Thomas RJ. The current and potential capacity for cardiac rehabilitation utilization in the United States. J Cardiopulm Rehabil Prev. 2014 Sep-Oct;34(5):318-26. doi: 10.1097/HCR.0000000000000076.

Results Reference

background

PubMed Identifier

26764059

Citation

Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044.

Results Reference

background

PubMed Identifier

11893790

Citation

Myers J, Prakash M, Froelicher V, Do D, Partington S, Atwood JE. Exercise capacity and mortality among men referred for exercise testing. N Engl J Med. 2002 Mar 14;346(11):793-801. doi: 10.1056/NEJMoa011858.

Results Reference

background

PubMed Identifier

18657659

Citation

Keteyian SJ, Brawner CA, Savage PD, Ehrman JK, Schairer J, Divine G, Aldred H, Ophaug K, Ades PA. Peak aerobic capacity predicts prognosis in patients with coronary heart disease. Am Heart J. 2008 Aug;156(2):292-300. doi: 10.1016/j.ahj.2008.03.017. Epub 2008 May 22.

Results Reference

background

PubMed Identifier

29944573

Citation

Pack QR, Bauldoff G, Lichtman SW, Buckley M, Eichenauer K, Gavic A, Garvey C, King ML; American Association of Cardiovascular and Pulmonary Rehabilitation Quality of Care Committee. Prioritization, Development, and Validation of American Association of Cardiovascular and Pulmonary Rehabilitation Performance Measures. J Cardiopulm Rehabil Prev. 2018 Jul;38(4):208-214. doi: 10.1097/HCR.0000000000000358.

Results Reference

background

PubMed Identifier

20051870

Citation

Soga Y, Yokoi H, Ando K, Shirai S, Sakai K, Kondo K, Goya M, Iwabuchi M, Nobuyoshi M. Safety of early exercise training after elective coronary stenting in patients with stable coronary artery disease. Eur J Cardiovasc Prev Rehabil. 2010 Apr;17(2):230-4. doi: 10.1097/HJR.0b013e3283359c4e.

Results Reference

background

PubMed Identifier

24057686

Citation

Iliou MC, Pavy B, Martinez J, Corone S, Meurin P, Tuppin P; CRS investigators and GERS (Groupe Exercice Readaptation, Sport) from French Society of Cardiology. Exercise training is safe after coronary stenting: a prospective multicentre study. Eur J Prev Cardiol. 2015 Jan;22(1):27-34. doi: 10.1177/2047487313505819. Epub 2013 Sep 20.

Results Reference

background

PubMed Identifier

17130385

Citation

Pavy B, Iliou MC, Meurin P, Tabet JY, Corone S; Functional Evaluation and Cardiac Rehabilitation Working Group of the French Society of Cardiology. Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. Arch Intern Med. 2006 Nov 27;166(21):2329-34. doi: 10.1001/archinte.166.21.2329.

Results Reference

background

Citation

Hamm LF. Point: High quality or just average - the need for exercise testing before cardiac rehabilitation. Journal of Clinical Exercise Physiology. 2013;2:42-45

Results Reference

background

Citation

McConnell TR. Counterpoint: All patients do no need an exercise test before starting cardiac rehabilitation. Journal of Clinical Exercise Physiology. 2013;2:45-48

Results Reference

background

PubMed Identifier

15665529

Citation

Scheinowitz M, Harpaz D. Safety of cardiac rehabilitation in a medically supervised, community-based program. Cardiology. 2005;103(3):113-7. doi: 10.1159/000083433. Epub 2005 Jan 19.

Results Reference

background

PubMed Identifier

12381088

Citation

Goto Y, Sumida H, Ueshima K, Adachi H, Nohara R, Itoh H. Safety and implementation of exercise testing and training after coronary stenting in patients with acute myocardial infarction. Circ J. 2002 Oct;66(10):930-6. doi: 10.1253/circj.66.930.

Results Reference

background

PubMed Identifier

11581152

Citation

Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Pina IL, Rodney R, Simons-Morton DA, Williams MA, Bazzarre T. Exercise standards for testing and training: a statement for healthcare professionals from the American Heart Association. Circulation. 2001 Oct 2;104(14):1694-740. doi: 10.1161/hc3901.095960. No abstract available.

Results Reference

background

PubMed Identifier

35383680

Citation

Shea MG, Headley S, Mullin EM, Brawner CA, Schilling P, Pack QR. Comparison of Ratings of Perceived Exertion and Target Heart Rate-Based Exercise Prescription in Cardiac Rehabilitation: A RANDOMIZED CONTROLLED PILOT STUDY. J Cardiopulm Rehabil Prev. 2022 Sep 1;42(5):352-358. doi: 10.1097/HCR.0000000000000682. Epub 2022 Mar 31.

Results Reference

derived

Learn more about this trial

Exercise Prescription in Cardiac Rehabilitation

We'll reach out to this number within 24 hrs